Lamivudine And Dolutegravir Simultaneous Dosage Forms Determined and Validated Using The RP-UPLC Method

Year : 2024 | Volume :01 | Issue : 01 | Page : 5-13
By

Sadaf Sultana

Mr.Shaik Ejas

  1. Student,Department of Pharmaceutical Analysis Mak college of Pharmacy Hyderabad, Telangana India
  2. Associate professor,Department of Pharmaceutical Analysis Mak college of Pharmacy Hyderabad, Telangana India

Abstract

RP-UPLC has been used to produce a straightforward, precise, and accurate approach for the simultaneous estimation of dolutegravir and lamivudine in a pharmaceutical dose form. A HSS C18 column of 2.8 x 50 mm and featuring particles with a size of 1.6 μm was used to process the chromatogram. A mixture of 70:30 Buffer Na2HPO4 and methanol made up the mobile phase, which was pushed across the column at a flow rate of 0.3 mL/min. This approach maintained a temperature of 30°C and employed potassium dihydrogen phosphate as the buffer. 260 nm was chosen as the ideal wavelength for detection. Dolutegravir and Lamivudine were shown to have retention durations of 1.739 and 1.408 minutes, respectively. The precision and accuracy of the approach were confirmed. Good precision was shown by the percentage relative standard deviation (%RSD) of 0.8% for both dolutegravir and lamivudine. As evidence of the method’s accuracy, the percentage recovery for dolutegravir (100.37%) and lamivudine (100.39%) was found. The limit of detection (LOD) and limit of quantification (LOQ) were also determined to assess the sensitivity of the approach. The LOD and LOQ values derived from the regression equations were 1.25 and 0.41 for lamivudine and 0.09 and 0.26 for dolutegravir, respectively. These results show that the analytes may be detected and quantified at low quantities using this approach. The effectiveness of this approach in terms of resources and time is one of its main advantages. The compounds’ retention durations were shortened, which resulted in a shorter run time overall. Because of this, the method can be applied to businesses where consistent, fast analysis is necessary for quality control testing. Additionally, the method’s simplicity makes it easy to apply in laboratory settings and cost-effective. To summarize, the RP-UPLC method that has been developed provides a simple and efficient way for estimating both dolutegravir and lamivudine simultaneously in pharmaceutical formulations. It is a useful instrument for quality control in the pharmaceutical business due to its high levels of precision, accuracy, sensitivity, and efficiency.

Keywords: RP-UPLC, Lamivudine, Dolutegravir, Pharmaceutical dosage form, Method validation

[This article belongs to Emerging Trends in Personalized Medicines(etpm)]

How to cite this article: Sadaf Sultana, Mr.Shaik Ejas. Lamivudine And Dolutegravir Simultaneous Dosage Forms Determined and Validated Using The RP-UPLC Method. Emerging Trends in Personalized Medicines. 2024; 01(01):5-13.
How to cite this URL: Sadaf Sultana, Mr.Shaik Ejas. Lamivudine And Dolutegravir Simultaneous Dosage Forms Determined and Validated Using The RP-UPLC Method. Emerging Trends in Personalized Medicines. 2024; 01(01):5-13. Available from: https://journals.stmjournals.com/etpm/article=2024/view=134713

Browse Figures

References

  1. Fox Z, Dragsted UB, Gerstoft J, Phillips AN, Kjaer J, Mathiesen L, Youle M, Katlama C, Hill A, Bruun JN, Clumeck N, Dellamonica P, Lundgren JD: A randomized trial to evaluate continuation versus discontinuation of lamivudine in individuals failing a lamivudine-containing regimen: the COLATE trial. Antivir Ther. 2006;11(6):761-70. [Article]
  2. FDA Approved Drug Products: Triumeq/Triumeq PD (abacavir, dolutegravir, and lamivudine) for oral administration [Link]
  3. Min S, Song I, Borland J, Chen S, Lou Y, Fujiwara T, Piscitelli SC: Pharmacokinetics and safety of S/GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2010 Jan;54(1):254-8. doi: 10.1128/AAC.00842-09. Epub 2009 Nov 2. [Article]
  4. Lenz JC, Rockstroh JK: S/GSK1349572, a new integrase inhibitor for the treatment of HIV: promises and challenges. Expert Opin Investig Drugs. 2011 Apr;20(4):537-48. doi: 10.1517/13543784.2011.562189. Epub 2011 Mar 8. [Article]
  5. 5. Anantha Kumar D, Srinivasa Rao G, JVLN SR (2010) Simultaneous determination of lamivudine, zidovudine and abacavir in tablet dosage form by RP-HPLC method. E J of Chem 7(1):180–184. https://doi.org/10. 1155/2010/473798
  6. Ashok G, Mondal DS (2018) Development and validation of stability indicating method for the simultaneous estimation of batcaver sulphate, lamivudine and dolutegravir sodium in pharmaceutical dosage forms by RP HPLC Saudi. J
  7. 7. Khaleel N, Sk AR (2015) A validated stability indicating RP-HPLC method for simultaneous determination of abacavir, lamivudine and dolutegravir in bulk and pharmaceutical dosage form. W J of Pharm. Res 4(7):1453–1476
  8. Mallikarjuna Rao N, Gowri Sankar D (2015) Development and validation of stability-indicating HPLC method for simultaneous determination of lamivudine, tenofovir and dolutegravir in bulk and their tablet dosage form. Future J Pharm Sci 1:73–77
  9. Vijayalakshmi R, Kalyani P, Sandya P, Dhanaraju MD (2013) Method development and validation of a reverse phase liquid chromatographic method for simultaneous determination of lamivudine and abacavir sulphate in tablets. A. J. of Phytomed and Clin. Therapeutics. 1(2):208–214
  10. Raja T, Lakshmana Rao A (2011) Development and validation of RP-HPLC method for estimation of abacavir, lamivudine and zidovudine in pharmaceutical dosage form. Int. J of Pharm Tech Res. 3(2):852–857
  11. Anil Yadav N, Mangamma K, Mani Kumar G (2013) Analytical method development and validation by RP-HPLC for the simultaneous estimation of abacavir sulphate and lamivudine in tablet dosage forms. Int. J. of Pharm, Chem. Bio Sci. 3(3):538–545
  12. Mastanamma S, Jyothi JA, Saidulu P (2018) Development and validation of RP-HPLC method for the simultaneous estimation of lamivudine, tenofovir alafenamide and dolutegravir bulk and their combined dosage form. Pharm Methods 9:49–55
  13. Sudha T, Ravi Kumar VR, Hemalatha PV (2008) RP-HPLC method for simultaneous estimation of Lamivudine and Abacavir sulfate in tablet form. Int. J. on Pharm. Biomed. Res. 1(4):108–113
  14. Pal N, Avanapu SR, Ravikumar P (2016) Simultaneous HPLC method development and validation for estimation of Lamivudine, Abacavir and Dolutegravir in combined dosage form with their stability studies. Asian J Chem 28:273–276
  15. Kenney BK, Wring AS, Carr MR, Wells NG, Dunn AJ (2000) Simultaneous determination of zidovudine and lamivudine in human serum using HPLC with tandem mass spectrometry. J. Pharm. Biomed. Anal 22:967–983
  16. Pereira SA, Kenney BK, Cohen SM, Hall EJ, Eron JJ, Tidwell RR, Dunn AJ (2000) Simultaneous determination of lamivudine and zidovudine concentrations in human seminal plasma using HPLC and tandem mass spectrometry. J Chrom. B. 742:173–183
  17. Bennetto-Hood C, Tabolt G, Paul MS, Edward P (2015) A sensitive HPLC-MS/ MS method for the determination of dolutegravir in human plasma. J Chrom. B. Analyt Tech. Biomed. Life Sci 15:225–232
  18. Sparidans WR, Hoetelmans WMR, Beijnen HJ (2001) Liquid chromatography assay for simultaneous determination of abacavir and mycophenolic acid in human plasma using dual spectrophotometric detection. J. of Chrom. B. 750:155–161
  19. Vikram Singh A, Nath LK, Pani NR (2011) Development and validation of analytical method for estimation of lamivudine in rabbit plasma. J Pharm Anal 1:251–257
  20. Sudha T, Ravikumar VR, Hemalatha PV (2010) Validated HPTLC method for simultaneous determination of lamivudine and abacavir sulfate in tablet dosage form. Int. J. Pharm Sci and Res. 1(11):101–111
  21. Bhavar GB, Pekamwar SS, Aher KB (2016) High-performance liquid chromatographic and high-performance thin-layer chromatographic method for the quantitative estimation of dolutegravir sodium in bulk drug and pharmaceutical dosage form. Sci Pharm 84:305–320
  22. Deepali G, Elvis M (2010) UV spectrophotometric method for assay of the anti-retroviral agent lamivudine in active pharmaceutical ingredient and in its tablet formulation. J Young Pharm JYP 2:417–419
  23. Balasaheb BG, Balasahen AK, Subhash TR, Jijabapu K (2015) Development and validation of UV spectrophotometric method for estimation of dolutegravir sodium in tablet dosage form. Malaysian J Anal Chem 19:1156–1163
  24. Madu KC, Ukoha PO, Attama AA (2011) Spectrophotometric determination of lamivudine using chloranilic acid and 2,3-dichloro-5,6-dicyano-1,4- benzoquinone (DDQ). Am J Anal Chem 2:849–856
  25. Sravan Kumar Reddy G, Ashutosh Kumar S, Raj Kumar V (2014) A new, simple, sensitive, accurate and rapid analytical method development and validation for simultaneous estimation of lamivudine, abacavir and zidovudine in tablet dosage form by using UPLC. Int. J. Pharm Sci and Res. 5(9):3852–3863
Regular Issue Subscription Original Research
Volume 01
Issue 01
Received March 2, 2024
Accepted March 12, 2024
Published Mar 20, 2024
Views: 87